An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

Periodic Fevers Syndrome Clinical Trial

Official title:

An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911857
• Other study ID #: CACZ885N2301E2
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2016
• Est. completion date: January 27, 2017

Study information

• Verified date: November 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan

• Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age

Exclusion Criteria:

• Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

Related Conditions & MeSH terms

• Amyloidosis
• Familial Mediterranean Fever
• Fever
• Mevalonate Kinase Deficiency
• Periodic Fevers Syndrome
• Syndrome

Intervention

Biological:
• Canakinumab (AIN457)
Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths	Participants were monitored for safety throughout the study.	Participants were followed for the duration until approval, an expected average of 3 months.